A Trial Comparing Transnasal humidified Rapid insufflation Ventilatory Exchange (THRIVE) and Apneic Oxygenation With Facemask Ventilation in Elderly Patients Undergoing Induction of Anaesthesia.
Primary Purpose
Anesthesia Intubation Complication, Postoperative Complications
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Transnasal humidified rapid insufflation ventilatory exchange (THRIVE)
Facemask ventilation
Sponsored by
About this trial
This is an interventional prevention trial for Anesthesia Intubation Complication
Eligibility Criteria
Inclusion Criteria:
- Patients who required induction of general anaesthesia for emergency surgery, whose routine clinical care required arterial blood gas sampling, and who were competent to give consent were recruited.
Exclusion Criteria:
- Patients who had severe respiratory disease.
Sites / Locations
- First Affiliated Hospital, Sun Yat-sen University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
THRIVE
Facemask
Arm Description
Using transnasal humidified rapid insufflation ventilatory exchange (THRIVE) oxygenation technique in elderly patients undergoing induction of anesthesia.
Using facemask technique in elderly patients undergoing induction of anesthesia.
Outcomes
Primary Outcome Measures
Postoperative respiratory complications
Extended apnoeic period
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03591432
Brief Title
A Trial Comparing Transnasal humidified Rapid insufflation Ventilatory Exchange (THRIVE) and Apneic Oxygenation With Facemask Ventilation in Elderly Patients Undergoing Induction of Anaesthesia.
Official Title
A Randomised Controlled Trial Comparing Transnasal humidified Rapid insufflation Ventilatory Exchange (THRIVE) Pre-oxygenation and Apneic Oxygenation With Facemask Pre-oxygenation and Ventilation in Elderly Patients Undergoing Induction of Anaesthesia.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 2018 (Anticipated)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
June 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Tao Zhang
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Induction of general anaesthesia in patients undergoing emergency surgery can be challenging, because of the often suboptimal circumstances under which anaesthesia has to be delivered, as well as potential physiological derangements caused by their underlying illness, especially in elderly patients. Pre-oxygenation is usually achieved using oxygen delivered via a facemask before induction of anaesthesia. In patients undergoing elective surgery, the lungs are normally ventilated with a bag/facemask technique after induction. However, these options for oxygenation are limited. Facemask ventilation has a perceived risk of gastric insufflation of gas, leading to increased intragastric pressure and raised risk of pulmonary aspiration of stomach contents. Nasal cannulae have been recommended as an alternative method of delivering continuous oxygen during induction of anaesthesia. The Aim of this study is to compare the effect of transnasal humidified rapid insufflation ventilatory exchange (THRIVE) oxygenation with facemask oxygenation on extended apnoeic period and postoperative respiratory complications in elderly patients undergoing induction of anaesthesia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia Intubation Complication, Postoperative Complications
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
THRIVE
Arm Type
Experimental
Arm Description
Using transnasal humidified rapid insufflation ventilatory exchange (THRIVE) oxygenation technique in elderly patients undergoing induction of anesthesia.
Arm Title
Facemask
Arm Type
Active Comparator
Arm Description
Using facemask technique in elderly patients undergoing induction of anesthesia.
Intervention Type
Device
Intervention Name(s)
Transnasal humidified rapid insufflation ventilatory exchange (THRIVE)
Intervention Description
Transnasal humidified rapid insufflation ventilatory exchange (THRIVE) is a new technique that is available for use in critically ill patients and in patients with difficult airways. The technique combines the benefits of apneic oxygenation and CPAP with a reduction in CO2 levels through gaseous mixing and flushing of the dead space. THRIVE is administered through a standard, commercially available, nasal, high-flow oxygen delivery system. Insufflation of O2 up to 70 L/min via a purpose-made nasal cannula is used initially to provide preoxygenation, which can be continued during intravenous induction until a definitive airway is secured. The THRIVE technique has been demonstrated to appreciably prolong the safe duration of apnea while avoiding increase in CO2.
Intervention Type
Device
Intervention Name(s)
Facemask ventilation
Intervention Description
Nowadays pre-oxygenation is usually achieved using oxygen delivered via a facemask before induction of anaesthesia; this potentially extends the time available for securing the airway before hypoxaemia to 6 min. In patients undergoing elective surgery, the lungs are normally ventilated with a bag/facemask technique after induction, and this can be repeated if attempts at intubating the trachea are prolonged.
Primary Outcome Measure Information:
Title
Postoperative respiratory complications
Time Frame
14 days after surgery
Title
Extended apnoeic period
Time Frame
during induction of anesthesia
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who required induction of general anaesthesia for emergency surgery, whose routine clinical care required arterial blood gas sampling, and who were competent to give consent were recruited.
Exclusion Criteria:
Patients who had severe respiratory disease.
Facility Information:
Facility Name
First Affiliated Hospital, Sun Yat-sen University
City
Guangzhou
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
21447488
Citation
Cook TM, Woodall N, Frerk C; Fourth National Audit Project. Major complications of airway management in the UK: results of the Fourth National Audit Project of the Royal College of Anaesthetists and the Difficult Airway Society. Part 1: anaesthesia. Br J Anaesth. 2011 May;106(5):617-31. doi: 10.1093/bja/aer058. Epub 2011 Mar 29.
Results Reference
background
PubMed Identifier
26556848
Citation
Frerk C, Mitchell VS, McNarry AF, Mendonca C, Bhagrath R, Patel A, O'Sullivan EP, Woodall NM, Ahmad I; Difficult Airway Society intubation guidelines working group. Difficult Airway Society 2015 guidelines for management of unanticipated difficult intubation in adults. Br J Anaesth. 2015 Dec;115(6):827-48. doi: 10.1093/bja/aev371. Epub 2015 Nov 10.
Results Reference
background
PubMed Identifier
25866645
Citation
Nishimura M. High-flow nasal cannula oxygen therapy in adults. J Intensive Care. 2015 Mar 31;3(1):15. doi: 10.1186/s40560-015-0084-5. eCollection 2015.
Results Reference
background
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A Trial Comparing Transnasal humidified Rapid insufflation Ventilatory Exchange (THRIVE) and Apneic Oxygenation With Facemask Ventilation in Elderly Patients Undergoing Induction of Anaesthesia.
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